Relacorilant, a Selective Glucocorticoid Receptor Modulator in Development for the Treatment of Patients With Cushing Syndrome, Does Not Cause Prolongation of the Cardiac QT Interval
Authors' conclusion
At all doses studied, relacorilant consistently demonstrated a lack of QTc prolongation in healthy volunteers and patients with CS, including in the TQT study. Ongoing phase 3 studies will help further establish the overall benefit-risk profile of relacorilant.
Study context
- Population
- Healthy volunteers and patients with CS3 studies
- Comparison
- Relacorilant vs placebo
- Outcome
- QTc change from baseline (ΔQTc)
Methodological detailsfirst-in-human randomized placebo-controlled ascending-dose study, phase 1 placebo- and positive-controlled thorough QTc study, phase 2 open-label study
- First-in-human randomized placebo-controlled ascending-dose study
- Phase 1 placebo- and positive-controlled thorough QTc study
- Phase 2 open-label study
Pooled result
As reported in the abstract
ΔQTc · all time points
- With all doses of relacorilant, including supratherapeutic doses, ΔQTc was small, generally negative and, in placebo-controlled studies, similar to placebo
- Thorough QTc (TQT) study: placebo-corrected ΔQTc with relacorilant small and negative; moxifloxacin showed rapid QTc prolongation; negative TQT study
- Model-estimated concentration-QTc slopes slightly negative, excluding an association of relacorilant with prolonged QTc
Safety
- No notable changes in ECG parameters across all studies
Original publication
Relacorilant, a Selective Glucocorticoid Receptor Modulator in Development for the Treatment of Patients With Cushing Syndrome, Does Not Cause Prolongation of the Cardiac QT Interval. Endocr Pract. Published 5 October 2023. doi:10.
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